Life Sciences & Healthcare

This highly regulated legal field encompasses several market sides and areas of law.
 
On the industry side, product regulations for the manufacturing and distribution of pharmaceuticals (medicinal products), medical devices and IVDs, genetic engineering/biotechnology, cosmetics, biocidal products and chemicals are relevant. On the healthcare side, rules and regulations for healthcare professionals (physicians, pharmacists, nurses) or healthcare organizations (hospitals, universities, group practices) apply. In addition, there are industry codes and practices (adopted by local agencies, associations, or PHARMIG and AUSTROMED). Finally, end customers and patient rights vis-à-vis the healthcare system and the industry (manufacturers, importers and distributors) are to be observed.
 
We advise on all legal, regulatory and cross-sectional aspects concerning these areas, whereby we place particular emphasis on clear, efficient and holistic legal advice.

Interdisciplinary advise

Efficient and clear legal advice and preparation of expert opinions on all legal and regulatory requirements

International strategies and project support

Project support and development of effective strategies, processes and risk analyses to avoid liability risks

Representation before national and European authorities

Professional representation before authorities, courts and EU institutions

Key areas

 
We advise and represent clients in the following areas in particular:
 
  • Pre-clinical and clinical studies/trials and performance evaluations as well as the drafting of trial-related contracts (CRO agreements etc.)
  • Marketing authorization procedures and conformity assessments (medicinal products, medical devices/IVDs, biocidal products, cosmetics)
  • Pricing and reimbursement (Austrian Reimbursement Code procedures)
  • Product launches and pre-marketing practices
  • Advertising and sales promotion of healthcare/medical products
  • Cooperation models between the industry and healthcare professionals, institutions and patients (patient organizations)
  • Congresses and marketing events
  • Business licenses, operating permits, facility authorizations
  • Industry codes and professional guidelines
  • Drafting contracts for healthcare professionals, pharmaceutical representatives and sales reps
  • Sales, distribution & quality assurance agreements
  • Product vigilance and product safety
  • Start-ups and transactions with regard to healthcare organizations
  • Life sciences M&A-transactions and reorganizations
  • Imports of medical products, product piracy and parallel imports
  • Patient rights and claims (warranties/guarantees, product liability, damages)